Title: Manager - Lead Investigation of UPD/OOS/OOTDate: Oct 21, 2024
Location: Halol 2 - Operations Block A
Company: Sun Pharmaceutical Industries Ltd
Position: Manager
Function: Production
Sub-function: Lead Investigation of UPD/OOS/OOT
Areas of Responsibility: Accountable for COE (Centre of Excellence) related activities.Overall responsible for production and packing activities related to Tablet, Soft Shell & Gel department.Responsible for daily production functions.Establishing new procedures and maintaining existing ones in the Tablet, Soft Shell & Gel department.Assist in establishing a system in accordance with Good Manufacturing Practice guidelines.Update, approve, and execute BMR, SOP, Protocol, and other GMP documents.Prepare daily reports to production manager/superiors on day-to-day activities.Coordinate with other departments like Administration, Warehouse, Quality Control, Quality Assurance, Quality Engineering, MIS, and Engineering.Co-maintain and coordinate for validation and GMP compliance with Quality Assurance and Quality Control departments.Train subordinates to meet organizational goals and achieve GMP compliance.Optimize resources: men, material, and machine in respective department.Standardize production activities to achieve better efficiency and product quality.Responsible for Calibration, Qualification, and Validation activities of equipment or products.Responsible for Production Planning, scheduling, control, and execution.Prepare and approve investigations in Trackwise.Initiate, review, and approve in Trackwise, Medhas Module, EDMS, SAP, LMS module access.Perform internal audits as an auditor.Prepare/review Risk assessments for new/existing products, evaluation, and approval.Manage activities of Rejection/Reprocessing based on Corrective actions from investigations.Ensure effective compliance with Regulatory Observations, report documentation, and approval.Procure machinery, change parts, spares, and materials required in respective department.Any other job assigned by the superior.
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